Ceftriaxone

   
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Ceftriaxone


Drug - Ceftriaxone
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; IM-IV
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ceftriaxone Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 2GM BASE/VIAL
The potency of the active ingredient(s), Ceftriaxone Sodium. May repeat for multiple part products.

Applicant - SANDOZ
The firm name holding legal responsibility for Ceftriaxone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065169
The FDA assigned number to Ceftriaxone. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Ceftriaxone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - May 9, 2005
The date Ceftriaxone was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Ceftriaxone. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Ceftriaxone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sandoz Inc
The full name of the firm holding legal responsibility for the new application of Ceftriaxone.

Ceftriaxone